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Cmc Chemistry Manufacturing Control Jobs (NOW HIRING)

Position Summary The Director, CMC - Formulations will contribute to the oversight, planning and execution of Chemistry, Manufacturing and Controls (CMC) strategy, including drug product formulations ...

Experience in CMC (Chemistry, Manufacturing, and Controls), pharmaceutical/biopharmaceutical ... deviations, CAPA, change control) is strongly preferred. * Strong mechanical aptitude and ...

Description NewLimit is recruiting a Head of Manufacturing to lead drug substance and product chemistry, manufacturing, and controls (CMC). We are creating a new class of epigenetic reprogramming ...

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Cmc Chemistry Manufacturing Control information

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How much do cmc chemistry manufacturing control jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for cmc chemistry manufacturing control in the United States is $31.59, according to ZipRecruiter salary data. Most workers in this role earn between $25.72 and $36.54 per hour, depending on experience, location, and employer.

What are some common challenges faced in a CMC (Chemistry, Manufacturing, and Controls) role, and how can professionals effectively address them?

Professionals in CMC roles often encounter challenges such as ensuring regulatory compliance across global markets, managing tight timelines for product development, and maintaining robust documentation for quality assurance. To address these, effective communication with cross-functional teams—including R&D, regulatory affairs, and manufacturing—is essential. Staying up-to-date with evolving regulatory guidelines and fostering a proactive approach to risk management can also help anticipate and mitigate issues before they impact project timelines or product quality.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) specialist, and why are they important?

To thrive as a CMC specialist, you need a strong background in chemistry, pharmaceutical sciences, or chemical engineering, often with an advanced degree and experience in regulatory submissions. Familiarity with analytical instrumentation, quality management systems, and regulatory guidelines such as ICH, FDA, and EMA requirements is essential. Strong project management, attention to detail, and effective communication skills are crucial for coordinating cross-functional teams and ensuring compliance. These skills are vital to ensure product quality, regulatory approval, and successful commercialization in the pharmaceutical industry.

What is the difference between Cmc Chemistry Manufacturing Control vs Cmc Quality Control?

AspectCmc Chemistry Manufacturing ControlCmc Quality Control
Primary FocusEnsuring manufacturing processes meet specifications and regulatory standardsTesting and verifying product quality through analysis
ResponsibilitiesProcess validation, batch documentation, complianceSampling, testing, release of products
Work EnvironmentManufacturing facilities, laboratories, regulatory settingsLaboratories, quality assurance departments
Required CredentialsScientific background, GMP knowledge, regulatory familiarityAnalytical skills, laboratory certifications, scientific education

While both roles are essential in pharmaceutical manufacturing, Cmc Chemistry Manufacturing Control focuses on overseeing manufacturing processes and compliance, whereas Cmc Quality Control emphasizes testing and verifying product quality. Understanding these distinctions helps clarify career paths and job expectations within the industry.

What is CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry?

CMC, or Chemistry, Manufacturing, and Controls, refers to the critical processes and documentation required to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. It covers everything from the chemical makeup of the drug, the manufacturing process, and quality control measures, to packaging and labeling. CMC is essential for regulatory submissions, as it demonstrates that a product is safe, effective, and of high quality. Regulatory agencies like the FDA and EMA require detailed CMC information for new drug approvals and ongoing compliance.
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What job categories do people searching Cmc Chemistry Manufacturing Control jobs look for? The top searched job categories for Cmc Chemistry Manufacturing Control jobs are:
Infographic showing various Cmc Chemistry Manufacturing Control job openings in the United States as of June 2026, with employment types broken down into 10% Full Time, 73% Part Time, and 17% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $65,713 per year, or $31.6 per hour.

Director, CMC - Formulations

Codera

San Diego, CA • Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago

Be an early applicant


Job description

Salary: 190,000 - 260,000

About Codera

Codera is a Tang Capital company that provides in-house, end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.


Position Summary

The Director, CMC - Formulations will contribute to the oversight, planning and execution of Chemistry, Manufacturing and Controls (CMC) strategy, including drug product formulations, in support of Coderas development programs. In collaboration with internal departments, such as nonclinical, clinical pharmacology and regulatory teams, the Director, CMC - Formulations will contribute to all aspects of chemistry, manufacturing and controls, including design of drug product formulations, oversight of vendors and production of regulatory documents.


Essential Duties and Responsibilities

  • Assist with the design and evaluation of drug product formulations, primarily small molecule formulations, to achieve specific pharmacokinetic (PK) goals
  • Contribute to CMC and development strategy
  • Manage relationships with various contract development and manufacturing organizations (CDMOs), analytical labs and contract research organizations (CROs)
  • Assist with the clinical supply logistics
  • Prepare, analyze and interpret analytical data that integrate into regulatory and intellectual property (IP) documents
  • Draft, edit and review sections of regulatory and IP documents
  • Provide scientific input for analytical protocols and study reports
  • Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence
  • Research CMC and formulation topics to support Tang Capitals investments
  • Participate in business development activities, as requested


Qualifications

  • Bachelors degree or higher in life sciences or related discipline required
  • Masters degree preferred
  • Minimum of 5 years in relevant pharmaceutical industry work experience required
  • Experience with small molecule formulations required
  • Experience with biologics formulations preferred
  • Experience working with CDMOs and analytical labs
  • Experience with one or more of the following drug product formulation strategies: modified/delayed release, fixed-dose combinations, spray-dried dispersions
  • Experience with a wide range of excipients and formulation technologies
  • Experience with formulations for oral, subcutaneous and/or inhaled delivery
  • Ability to research, synthesize and summarize complex CMC topics
  • Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND)/New Drug Application (NDA) sections
  • Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission
  • Excellent knowledge of Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations and Good Manufacturing Practices (GMP)
  • Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
  • Ability to establish and maintain collaborative working relationships with internal and external stakeholders



The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.


The estimated annual base salary for this position is $190,000 - $260,000, commensurate with experience and skills. This role may be eligible for discretionary bonuses and other incentive programs.


Codera provides a comprehensive benefits package designed to support employees physical, mental and financial health and include employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs


Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.


Codera participate in EVerify. All newly hired employees are required to complete the EVerify process as part of their employment eligibility verification.